Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal

Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal: a Crossover Randomized Study

Over time, many different types of manual and electric toothbrushes have been produced. A systematic review has shown that some electric toothbrushes are more effective at removing bacterial plaque than manual toothbrushes. A new U-shaped electric toothbrush with silicone bristles has recently been produced that has a fully automatic and simultaneous action on both arches. However, its efficacy in removing bacterial plaque is not clear at the moment, as no randomized study has been published on this type of toothbrush.

The aim of this study is to compare the efficacy in terms of bacterial plaque removal in a single use of a new automatic U-shaped electric toothbrush, compared with the usual home toothbrushing procedure, a conventional electric toothbrush, and negative control (no toothbrushing) in a group of volunteer students of the School of Dentistry of the University of Florence, Italy.

Primary endpoint will be the difference in "full mouth plaque score" between before and after brushing. Secondary endpoints will be feeling of "clean mouth" evaluated on a VAS (Visual Analogue Scale) scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth.

This study will be a monocentric, randomized, controlled, superiority, cross-over study, with blind examiner and 4 therapies (U-shaped electric toothbrush, usual home toothbrushing procedure, conventional electric toothbrush, no toothbrushing), carried out in a single session with an interval of one week between the 4 therapies.

Study population will be students of the School of Dentistry who are healthy volunteers. Number of patients to be enrolled: 22. Inclusion criteria: age between 18 and 30 years; no fixed orthodontic appliance; presence of at least 20 teeth; Full mouth plaque score (FMPS) above 40%.

Exclusion criteria: subjects with manual disabilities to perform normal oral hygiene maneuvers; subjects allergic to silicone.

Study Overview

• Status: Completed
• Conditions: Dental Plaque; Toothbrushing
• Intervention / Treatment: Device: U-shape Automatic Electric Toothbrush; Other: Usual home toothbrushing procedure; Other: Conventional Electric Toothbrush

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Firenze, Italy, 50127
    • SOD Odontostomatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 30 years;
• no fixed orthodontic equipment;
• presence of at least 20 teeth;
• Full mouth plaque score (FMPS) above 40%.

Exclusion Criteria:

• Subjects with manual disabilities to perform normal oral hygiene maneuvers;
• Subjects allergic to silicone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: U-shape Automatic Electric Toothbrush	Device: U-shape Automatic Electric Toothbrush; The U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste.
Active Comparator: Usual home toothbrushing procedure	Other: Usual home toothbrushing procedure; Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.
No Intervention: No toothbrushing
Active Comparator: Conventional Electric Toothbrush	Other: Conventional Electric Toothbrush; The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full mouth plaque score	Percentage of sites that presents with plaque on the total of the sites examined (6 sites per tooth).	Difference between pre- and post-brushing (time frame 10-15 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeling of "clean mouth"	Visual analogue scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum feeling of clean mouth	Post-brushing (time frame 1-2 minutes)

Collaborators and Investigators

• Sponsor: University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): February 14, 2020
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 6, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: IUFET1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No